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The European Medicines Agency (EMA) addresses the unique needs of micro, small and medium-sized enterprises (SMEs) through the SME office. This dedicated interface has the sole remit of providing regulatory, financial and administrative assistance to small pharmaceutical companies.

Benefits

Administrative, regulatory and financial support is available to companies assigned SME status by EMA, including:

direct assistance by phone, email, teleconference or through briefing meetings on regulatory aspects of the pharmaceutical legislation. SMEs receive help on how to navigate the array of services available, support in identifying the most relevant guidance, or advice on regulatory strategy for a product development or authorisation;

inclusion in an online SME register. The register is an important source of information on EU/European Economic Area-based SMEs involved in the manufacturing, development or marketing of medicines and promotes partnering and networking between SMEs;

SME user guide

EMA's SME user guide helps enterprises navigate the regulatory requirements and the incentives available throughout a medicine's product lifecycle. It provides an overview of procedures to support research and development activities, and improves understanding of what is needed to obtain marketing authorisation.

Financial incentives

EMA fee incentives are applied if an enterprise has been assigned SME status by the Agency. Companies are advised to register as an SME or renew their status well in advance of a planned regulatory submission to the EMA. Applicants do not need to obtain confirmation of a fee incentive from the Agency. Conditional fee exemptions, where applicable, should be requested at the time of dossier outcome (see below).

Pharmacovigilance fee incentives

Fee incentives relating to pharmacovigilance activities are applied if an enterprise has been assigned SME status by the Agency, or has submitted a SME declaration or renewal to the Agency. Pharmacovigilance fees will be subject to corrections where an enterprise wrongly claims a fee incentive for pharmacovigilance activities.

Companies are therefore advised to contact the SME office for any question relating to the SME definition prior to formally submitting a SME declaration in relation to pharmacovigilance fees.

The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. EMA is in the process of making appropriate changes to this website. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed.